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Jason Johal at CK Scienceis recruiting for a Pharmaceutical Technical Executive to join an international speciality Pharmaceuticalcompany based in London on a 6 month initial contract.

This is an excellent opportunity to join a growing pharmaceutical company with several new products launched this year and several more in the pipeline. As Pharmaceutical Technical Executive you will gain excellent development experience, and attractive salary and excellent personal development opportunities.

The Role:

As Pharmaceutical Technical Executive you will:

– Provide a technical support service to the Medical and Regulatory Affairs Unit

– Advise on all relevant product issues

– Approve technical documentation provided by third parties

– Investigate and resolve technical issues from manufacturers

– Be involved in site transfer projects

– Be responsible for compliance documents

– Be responsible for expert document writing

– Apply for licences

Qualifications, Skills and Experience:

The successful Pharmaceutical Technical Executive will have the following qualifications, skills & experiences:

– BSc in Pharmacy or Chemistry or equivalent

– Relevant technical experience gained in the pharmaceutical industry

– Regulatory experience of CMC documentation (essential)

– Manufacturing experience (essential)

– CMC sections experience

– Document control experience (essential)

– Regulatory knowledge needed including regulatory licensing

– Product development experience

– Technical knowledge across a range of dosage forms (tableting experience is essential)

Nolato have bought Cope Allman Jaycare for an initial SEK 179 million (USD $26 million) and a deferred consideration based on earnings up to and including the first quarter of 2014.

Cope Allman Jaycare has a history within pharmaceutical packaging dating back to 1958. The company has 270 employees at its plants in Portsmouth and Newcastle. They have annual sales of around SEK 270 million (USD $39 million), and its customers comprise of a number of international pharmaceutical companies.

Christer Wahlquist, president of Nolato Medical, in a press release said “Nolato already has a strong position in the Scandinavian pharmaceutical packaging market…….This acquisition gives us a local presence in the UK, which is an important part of the global pharmaceutical industry. It also opens doors with a large number of leading international pharmaceutical companies, which are existing customers of Cope Allman Jaycare.”

Oval Medical Technologies are experts in the design and development of drug delivery devices on vials, prefilled syringes and autoinjectors.

The substantial investment has come from AptarGroup, who now own a 20 per cent stake in Oval. They are recognised as the market leader in the development and manufacture of innovative drug delivery services.

The investment will enable Apta Pharma, the division of the company which specialises in working with the pharmaceutical and biotech industries, to enter new categories, broaden it’s product portfolio and overall reach.

Oval is currently working with pharmaceutical companies to help customise devise for specific therapeutic areas. Currently, they are in the process of developing a novel auotinjector which is smaller and safer to use than any other device on the market.

Speaking of the news, Oval chairman, Peter Keen stated,

“Aptar Pharma’s recognised experience and global presence will enhance Oval’s credibility within the pharmaceutical market and we are delighted that they have become our preferred manufacturing partner.

“Oval will benefit from their experience and particularly as it moves forward and prepares for the scale up of its technology. The investment will provide Oval with financial resources to develop and commercialise its autoinjector technology more rapidly thereby ensuring that it remains a leader in the field.”

A research team has discovered a new pharmaceutical on Easter Island which could be used to reverse the effects of aging, the Telegraph reports.

A chemical discovered in the soil of the island has been used to create Rapamycin which, when tested on children suffering from Hutchinson-Gilford Progeria Syndrome (HGPS), a disease which prematurely ages children, helped clear their cells of defects.

Researchers are already looking into the possibility of providing the drug to a wider market, after similarities between normal aging and HGPS were discovered. Dimitri Krainc, an author of the study into Rapamycin, believes a small dose of the drug can “extend the health and life span of our cells and organs”.

Our client is a world leader in the production of medical visualisation and energy systems for the medical devices industry based in South Wales. The company are currently looking to recruit a contract Quality Engineer to support implementation of Quality Engineering Activities in product design, manufacture and vendor quality assurance in accordance with Company procedures and regulatory requirements.

Essential Duties and Responsibilities:

As a Quality Engineer, you will have the following duties and responsibilities:

Support operations or as a new design project member, providing directed quality engineering and regulatory expertise in support of design projects. Ensuring solutions are compliant, in the most efficient manner with ISO 13485, FDA 21, CFR Part 820, MDD 93-42-EEC, and their associated applicable consensus standards (IEC60601 series, ISO 11607, ISO 10993).

Take a role in ensuring approximate risk management tools such as risk analysis, pFMEA and dFMEA are performed adequately.

Review and approval of quality related documentation via ORACLE PLM or other systems including software, mechanical and electronic technology aspects.

Assist in the development of appropriate verification and validation strategies including test method validationfor products, processes and components.

Where required liaison with vendors including auditing and co-ordination of component qualification activities.

Where required support of CSV activity.

Provide ad hoc Quality Engineering support in other areas such as; other projects, operations problem analysis, process analysis and process and vendor improvements.

All other essential duties as directed.

To adhere to the “Rules and Regulations’ of the company as laid out in the Staff Handbook.

Education:

The successful candidate for this Quality Engineer position will have the following educational qualifications:

HND or equivalent calibre in engineering, science or technology discipline.

Proven experience in a quality related field.

Preferably experience of a Medical Device environment or similar regulated industry.

Exposure to quick evolving environments with cross functional team working.

Essential Knowledge, Skills and Abilities:

Ability to interpret technical drawings and specifications.

Basic understanding design and manufacturing processes.

Strong metrology skills and understanding of inspection techniques and schemes.

Awareness of FMEA or other risk analysis techniques.

Experience of use of ORACLE PLM, MS Ecxel,MS Word and Minitab or equivalent.

Ability to review technical documentation and drawings in a consistent, constructive and timely manner.

Appreciation of vendor quality system auditing skills and vendor development ability.

Application of a wide range of inferential statistical techniques.

Excellent report writing and presentation skills.

Appreciation of requirements of working in a regulatory controlled environment.

Apply Now

For more information or to apply for this Quality Engineer job please contact Russell Oakley at CK Science on 0114 283 9956 or email roakley@ckscience.co.uk. Please quote reference SH20964 in all correspondence.